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A Phase II Study of Three Hour, Weekly Infusion of ET 743 (Yondelis) in Men With Advanced Prostate Cancer
The main purpose of this study is to find out what effects (good or bad) trabectedin (ET743) has on men with advanced prostate carcinoma.
* Treatment with trabectedin will be given once a week for three consecutive weeks with one week of no treatment. This four week period constitutes one cycle. * Trabectedin is given as an infusion through a central venous catheter and is administered over 3 hours. * On day 1 of each cycle a history, physical exam and blood tests will be performed and trabectedin will be administered. * On day 8 and day 15 of each cycle blood work will be performed and trabectedin will be administered. * Patients will continue to receive trabectedin as long as there is no disease progression or unacceptable side effects. * Scans (CT, MRI or bone) or x-rays may be done while the patient is on the trial at the discretion of the physician.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Masachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Start Date
June 1, 2002
Primary Completion Date
April 1, 2008
Completion Date
April 1, 2008
Last Updated
January 18, 2013
50
ACTUAL participants
ET 743
DRUG
Lead Sponsor
Massachusetts General Hospital
Collaborators
NCT04550494
NCT05691465
Data Source & Attribution
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